Senior Manager Medical Devices and Combination Products Quality Operations

Use Your Power for Purpose

Everything we do every day is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible innovative and customer oriented. Whether you are involved in development maintenance compliance or analysis through research programs your contribution will directly impact patients.

What You Will Achieve

This position is part of Pfizers Medical Device and Combination Products (MDCP) Quality Operations team. As Sr. Manager of Medical Device Quality Assurance Development you will be responsible for ensuring that product development teams comply with design control and regulatory standards (21 CFR 820 ISO 13485 ISO 14971) throughout the entire product lifecycle. The role supports the delivery of the Medical Device and Combination Products development portfolio in collaboration with the Pfizer Pharmaceutical Sciences Organization. You will work closely with cross-functional teams to establish innovative methodologies facilitate agreements and rigorously review deliverables to guarantee product safety compliance and efficacy. Your specialized knowledge will contribute to achieving team goals within Pfizers quality system necessitating exceptional communication analytical and consensus-building abilities. This role requires a self-motivated professional who can proactively identify and address issues communicate across all organizational levels prioritize quality assist in completing critical deliverables clarify complex matters and foster effective teamwork.

How You Will Achieve It

• Oversees and ensures compliance with SOPs quality standards (e.g. 21 CFR 820 ISO 13485 IEC 62366 IEC 62304 ISO 14971) and regulatory requirements including conducting audits identifying areas for improvement and implementing corrective actions.

• Routinely provides guidance and interpretation of SOPs and standards within PharmSci and with external partners.

• Act as the quality assurance and medical device quality lead supporting MDCPs through reviews and approvals of all MDCP lifecycle documentation including design controls risk management quality management systems change controls vendor management and complaints.

• Monitor changes to global regulations and ensure policies and procedures reflect applicable changes implements quality system best practices and communicates company-wide policies on quality system effectively.

• Identifies leads development of and participates in implementation of new processes/programs for quality improvement initiatives with the MDCP space.

• Proactively seeks global alignment / interpretation in application of policy / procedure.

• MDCP Quality Assurance oversight of facility utilities equipment computer system validations and change controls. Support Management Review & Quality Councils as required.

• Has technical and quality knowledge on later phase product life cycle strategies (e.g. design verification design validation process validation ICH stability etc.). Leads and advises as needed.

• Expert in quality investigation techniques and leads complex quality investigations and develops QA decisions. Actively contributes to PSQRT/AQRT.

• Creates develops and delivers training courses; performs review of training effectiveness identifies trends and develops actions to remediate compliance issues as required.

• Evaluates highly complex quality issues on projects or with vendors and provides suggested issue resolutions.

• Recognized as a coach mentor and technical expert; participates as an external influencer at conferences or standard committees.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with at least 6 years of experience; OR a masters degree with at least 5 years of experience; OR a PhD with 1 years of experience

• Thorough understanding and application of one of the following: 1) cGMP and current good manufacturing practices in a pharmaceutical environment 2) 21 CFR 820 Rule 21 CFR 4 current good manufacturing requirements for Combination Products or 3) medical devices and/or combination products including ISO 13485 & ISO 14971

• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments gathering input from colleagues and management to address issues

• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement

• Strong leadership negotiation interpersonal communication and facilitation skills

• Strong analytical and computer skills are required.

Bonus Points If You Have (Preferred Requirements)

• The combination of strong pharmaceutical and / or medical device development experience preferred

• Thorough understanding and application of cGMP specifically 21 CFR 820 Rule 21 CFR 4 current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems

• Extensive experience in risk management and design control of medical devices combination products from concept through launch or pharmaceutical manufacturing operations in a GMP environment

• Proven ability to succeed in a fast-paced challenging and complex environment

• Proven ability to mentor engineers

• Experience interacting with FDA investigators and other regulatory agencies.

• Knowledge and application of device root cause analysis methodology and device CAPA requirements.

• Experience in change management (pre and post launch) of either medical devices or medical device combination products.

• ISO 13485 Lead Auditor Certification

Non-Standard Work Schedule Travel or Environment Requirements

• The role may include frequent business travel across Pharmaceutical Sciences vendors and suppliers.

Other Job Details

• Work Location Assignment:Hybrid - On premise 2-3 days per week at a Europe US Latam Central America Pfizer location

Work Location Assignment:Hybrid

Relocation assistance may be available based on business needs and/or eligibility.